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Drug Safety Associate

2-4 years
Not Disclosed
10 March 2, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Drug Safety Associate

Company: Novotech

Experience: 2 - 4 Years

Location: Bangalore

Qualification: B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Life Sciences

Posted On: February 21, 2025

Job Type: Verified Job

Application Mode: Online Application

Job Highlights:

  • Work/Life Balance
  • Time Management
  • Challenging Projects
  • Insurance

Job Description:

Novotech is seeking a Drug Safety Associate for its Bangalore location. This role focuses on pharmacovigilance, ensuring drug safety in clinical trials and post-marketing surveillance. Candidates will be responsible for monitoring safety data, processing adverse event reports, and maintaining regulatory compliance.

Key Responsibilities:

  • Project Management: Prepare safety management plans, set up safety databases, and create project kick-off materials.
  • Case Processing: Draft safety narratives, monitor safety mailboxes, and maintain Trial Master File (TMF) documentation.
  • Regulatory Compliance: Ensure timely submission of safety reports to regulatory agencies.
  • Collaboration: Work closely with medical monitors, drug safety physicians, and study teams.
  • Training: Mentor junior staff and support team development.
  • Other Responsibilities: Conduct literature searches for adverse events and support audits.

Eligibility Criteria:

Education & Experience:

  • Degree in Nursing, Pharmacy, or Health/Biomedical Sciences (postgraduate qualifications preferred).
  • 2-4 years of experience in pharmaceuticals or CROs, focusing on safety in clinical trials.

Skills Required:

  • Strong knowledge of pharmacovigilance and clinical trial regulations (ICH-GCP, SOPs).
  • Familiarity with medical coding (e.g., MedDRA) and safety databases.
  • Excellent English communication skills with the ability to summarize medical data.
  • Strong time management and multitasking skills.

Why Join Novotech?

Novotech is a global leader in biotech and clinical research, with 34 offices worldwide and over 3,700 clinical projects. The company offers:

  • Flexible work hours
  • Paid parental leave
  • Wellness programs
  • An inclusive workplace supporting LGBTIQ+ individuals, people with disabilities, and caregivers
  • ISO 27001 and ISO 9001 certifications ensuring high-quality standards

Industry Outlook:

Pharmacovigilance in India is rapidly growing, with the market expected to expand at a CAGR of 11.5% through 2030. This makes it an excellent time to pursue a career in drug safety.